Ahead of a congressional hearing today, FDA announced that it is releasing a draft guidance that will speed the issuance of calls and spell out what should be in company warnings to consumers. The guidance also advises companies on when FDA would issue its own warnings to consumers.
The guidance will apply to animal and human drugs as well as food. The release of the guidance follows a report issued last month by the inspector general at the Department of Health and Human Services on FDA’s food-recall procedures.
The IG report, which was based on a review of cases during the Obama administration, found deficiencies in FDA’s oversight of recall initiation, its monitoring of recalls, and the agency’s tracking of information. Before the investigation was completed, the investigators issued an “early alert” memo warning agency officials of the preliminary findings.
In addition to issuing the guidance, FDA also is developing a new policy on what information the agency will disclose to consumers to help them identify recalled food products. One step the agency says it could take is to start identifying the specific stores where recalled products were sold.
“Our recall authorities – and how we deploy them – are a cornerstone of our vital, consumer protection mission and I take these obligations very seriously,” said FDA Commissioner Scott Gottlieb.
A House Energy and Commerce subcommittee is holding a hearing on FDA’s recall procedures this morning. From Agri-Pulse
